Biothera Pharmaceuticals is an immuno-oncology company dedicated to unlocking the promise of cancer immunotherapy.
We are developing Imprime PGG in combination therapy with immune checkpoint inhibitors (CPIs) in multiple cancer indications. Imprime PGG is a Pathogen Associated Molecular Patterning (PAMP) molecule that triggers a cascade of innate immune system responses that increase T cell activation and infiltration at the site of a tumor, which is critical to CPI effectiveness. Imprime PGG also alters the protective microenvironment tumors often create to avoid detection and destruction. As a result, cancer cells become more vulnerable to immune attack.
We are currently collaborating with Merck and academic institutions to evaluate Imprime PGG in combination with Merck’s anti-PD-1 CPI, Keytruda®, in Phase 2 clinical trials in melanoma, triple negative breast cancer, non-small cell lung cancer, and squamous cell carcinoma of the head and neck. We also have a clinical collaboration with Genentech to study Imprime PGG in combination with Tecentriq®, an anti-PD-L1 CPI, and Avastin®, an anti-angiogenic monoclonal antibody, in metastatic colorectal cancer. Clinical data readouts are expected throughout 2018 and 2019.
Our clinical development strategy is to establish proof of concept for Imprime PGG in combination with CPIs in multiple tumor types. Our initial focus is on tumor types and patient populations with limited response to single agent CPIs. We also are striving to expand understanding of Imprime PGG’s mechanism of action through advanced imaging technology to analyze pre- and on-treatment tumor biopsies for Imprime PGG-mediated immunological activity in the tumor bed.
Imprime PGG has demonstrated signals of activity in multiple cancer indications and therapeutic combinations. These studies have generated safety experience in more than 500 subjects (>400 cancer patients) and have led to the identification of a mechanism-based biomarker for selecting patients most likely to respond to Imprime PGG therapy. Unlike other innate immune modulators, Imprime PGG’s novel mechanism of action allows intravenous administration for systemic activity to treat local and distant tumors.
Further, Biothera has assembled a broad intellectual property portfolio for Imprime PGG consisting of more than 100 US and international patents and patents pending. Our leadership team has extensive experience in all aspects of oncology drug development, including translational research, clinical development and trial management, and commercialization.
We strive to become the recognized leader in innate immune modulation. We envision our novel therapeutics becoming essential components of multiple cancer immunotherapy combinations that enable more patients to live longer and healthier lives. And that is the promise of cancer immunotherapy.